Neumann Thomas, Vogt Jürgen, Schumacher Burghard, Dorszewski Anja, Kuniss Malte, Neuser Hans, Kurzidim Klaus, Berkowitsch Alexander, Koller Marcus, Heintze Johannes, Scholz Ursula, Wetzel Ulrike, Schneider Michael A E, Horstkotte Dieter, Hamm Christian W, Pitschner Heinz-Friedrich
Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
J Am Coll Cardiol. 2008 Jul 22;52(4):273-8. doi: 10.1016/j.jacc.2008.04.021.
The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device (Arctic Front, Cryocath, Quebec, Canada).
Antral pulmonary vein (PV) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation (PAF). A novel double lumen cryoballoon catheter was designed for circumferential pulmonary vein isolation (PVI) with the cryoablation technique.
We consecutively enrolled 346 patients with symptomatic, drug refractory paroxysmal (n = 293) or persistent (n = 53) atrial fibrillation (AF). In all patients, PVI of all targeted PVs was the therapeutic aim. The primary end points of this nonrandomized study were: 1) acute isolation rate of targeted PV; and 2) first electrocardiogram-documented recurrence of AF. The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula.
The 1,360 of 1,403 PVs (97%) were targeted with balloons or balloons in combination with the use of Freezor Max (Cryocath). We found that ablation with the cryoballoon resulted in maintenance of sinus rhythm in 74% of patients with PAF and 42% of patients with persistent AF. No PV narrowing occurred. The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV.
Pulmonary vein isolation with a new cryoballoon technique is feasible. Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system. Cryoablation was less effective in patients with persistent AF than in patients with PAF.
本研究旨在探讨新型冷冻球囊装置（北极锋，Cryocath公司，加拿大魁北克）的疗效和安全性。
采用射频能量进行肺静脉前庭消融术被广泛用作阵发性心房颤动（PAF）导管消融的一种策略。一种新型双腔冷冻球囊导管被设计用于采用冷冻消融技术进行肺静脉隔离（PVI）。
我们连续纳入了346例有症状、药物难治性阵发性（n = 293）或持续性（n = 53）心房颤动（AF）患者。对所有患者而言，所有目标肺静脉的PVI是治疗目标。这项非随机研究的主要终点为：1）目标肺静脉的急性隔离率；2）首次心电图记录到的房颤复发。次要终点是肺静脉狭窄或心房食管瘘的发生情况。
1403条肺静脉中的1360条（97%）接受了球囊或球囊联合Freezor Max（Cryocath）治疗。我们发现，使用冷冻球囊消融使74%的PAF患者和42%的持续性AF患者维持了窦性心律。未发生肺静脉狭窄。最常见的并发症是在右上肺静脉进行冷冻球囊消融时观察到的右侧膈神经麻痹。
采用新的冷冻球囊技术进行肺静脉隔离是可行的。通过使用冷冻球囊消融系统进行环周PVI，大多数PAF患者可维持窦性心律。冷冻消融对持续性AF患者的疗效低于PAF患者。
